Improving Uptake of Early Infant Diagnosis of HIV for the Prevention of Mother-to-child Transmission of HIV (SMS4PMTCT)
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ClinicalTrials.gov Identifier: NCT01433185 |
Recruitment Status
:
Completed
First Posted
: September 13, 2011
Last Update Posted
: January 21, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Acquired Immunodeficiency Syndrome | Other: Text message | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 388 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Improving Uptake of Early Infant Diagnosis of HIV for PMTCT: a Randomized Trial of a Text Messaging Intervention |
Study Start Date : | April 2012 |
Actual Primary Completion Date : | July 2013 |
Actual Study Completion Date : | July 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Text message (SMS)
Text messages sent to women before and after delivery
|
Other: Text message
Text messages sent to women before and after delivery
Other Name: SMS, short message service, text messaging
|
No Intervention: Usual care (current standard of care)
Current standard of care for women enrolled in PMTCT programs
|
- Proportion of women who attend postnatal clinic within 6-8 weeks postpartum [ Time Frame: 6-8 weeks after delivery ]
- Proportion of infants tested for HIV by DNA PCR [ Time Frame: 6-8 weeks after delivery ]
- Infant adherence to antiretroviral prophylaxis [ Time Frame: Up to 6 weeks after delivery ]
- Time to post-natal clinic return [ Time Frame: Up to 8 weeks after delivery ]
- Maternal adherence to antiretroviral prophylaxis [ Time Frame: Up to 8 weeks after delivery ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- age at least 18 years
- report ability to read SMS
- ≥ 28 weeks gestation or delivery at study clinic on day of enrollment
- HIV positive women enrolled in the PMTCT program
- have access to a mobile phone (personal or partner's if HIV serostatus disclosed to partner)
- willing to receive SMS messages from the study
- planning to remain in the study area (Nyanza province) for the duration of the study
Exclusion Criteria:
- age less than 18 years old
- women who share phones with partners but HIV status not disclosed to partners
- intention to deliver at a non-study hospital

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01433185
Kenya | |
Kenya Medical Research Institute, Family AIDS Care and Education Services | |
Kisumu, Nyanza, Kenya |
Principal Investigator: | Thomas A Odeny, MBChB, MPH | University of Washington/Kenya Medical Research Institute | |
Study Chair: | R Scott McClelland, MD, MPH | University of Washington | |
Study Chair: | Craig R Cohen, MD, MPH | University of California, San Francisco | |
Study Chair: | Carol Camlin, PhD | University of California, San Francisco | |
Study Chair: | Elizabeth A Bukusi, MBChB, MMed, MPH, PhD | Kenya Medical Research Institute |
Publications of Results:
Responsible Party: | Thomas Odeny, Principal Investigator, University of Washington |
ClinicalTrials.gov Identifier: | NCT01433185 History of Changes |
Other Study ID Numbers: |
41186-E/G |
First Posted: | September 13, 2011 Key Record Dates |
Last Update Posted: | January 21, 2015 |
Last Verified: | January 2015 |
Keywords provided by Thomas Odeny, University of Washington:
PMTCT SMS HIV Infections Acquired Immunodeficiency Syndrome |
Prevention & Control Patient Compliance Cellular Phone Randomized Controlled Trial |
Additional relevant MeSH terms:
HIV Infections Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immune System Diseases Slow Virus Diseases |